Section 180-7-044 - USE OF UNSEALED RADIOACTIVE MATERIAL FOR IMAGING AND LOCALIZATION STUDIES FOR WHICH A WRITTEN DIRECTIVE IS NOT REQUIREDA licensee may use, for imaging and localization studies, any radioactive material prepared for medical use, in quantities that do not require a written directive as described in 180 NAC 7-019 that is:
(A) Obtained from: (i) A manufacturer or preparer licensed according to 180 NAC 3-014.10 or equivalent NRC or Agreement State; or(ii) A PET radioactive drug producer licensed according to 180 NAC 3-010.11 or equivalent NRC or Agreement State; or(B) Excluding production of PET radionuclides, prepared by: (i) An authorized nuclear pharmacist;(ii) A physician who is an authorized user and who meets the requirements specified in 180 NAC 7-047, or 7-051 and 7-047.03(A)(ii)(7); or(iii) An individual under the supervision, as specified in 180 NAC 7-018, of the authorized nuclear pharmacist in paragraph 180 NAC 7-044(B)(i) or the physician who is an authorized user in paragraph 180 NAC 7-044(B)(ii); or(C) Obtained from and prepared by an NRC or Agreement State licensee for use in research according to a Radioactive Drug Research Committee approved protocol or an Investigational New Drug (IND) protocol accepted by the FDA; or(D) Prepared by the licensee for use in research according to a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by the FDA.180 Neb. Admin. Code, ch. 7, § 044
Amended effective 11/3/2020Amended effective 6/14/2023